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Sponsored by: |
Nihon Univerity |
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Information provided by: | Nihon Univerity |
ClinicalTrials.gov Identifier: | NCT00636831 |
The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.
Condition | Intervention | Phase |
---|---|---|
Inguinal Hernia |
Drug: Antibiotic: cefazolin Sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-Controlled, Double-Blind Trial |
Estimated Enrollment: | 300 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
cont: Placebo Comparator |
Drug: Antibiotic: cefazolin Sodium
1g continuous IV at 30 minutes before starting operation
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intervention: Active Comparator |
Drug: Antibiotic: cefazolin Sodium
1g continuous IV at 30 minutes before starting operation
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Takero Mazaki, MD, PhD | 81339793611 ext 8112 | tmazaki@med.nihon-u.ac.jp |
Japan | |
Nihon University School of Medicine, Department of Surgery | Recruiting |
Tokyo, Japan, 179-0072 | |
Principal Investigator: Takero Mazaki, MD, PhD |
Responsible Party: | Nihon University Nerima-Hikarigaoka Hospital ( Takero Mazaki ) |
Study ID Numbers: | Hikari-0701 |
Study First Received: | March 10, 2008 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00636831 History of Changes |
Health Authority: | Japan: Nihon University School of Medicine Herima-Hikarigaoka Hospital |
Prophylactic Antibiotic Infection Primary case |
Pathological Conditions, Anatomical Anti-Bacterial Agents Cefazolin |
Hernia Hernia, Abdominal Hernia, Inguinal |
Pathological Conditions, Anatomical Anti-Infective Agents Anti-Bacterial Agents Cefazolin Therapeutic Uses |
Hernia Hernia, Abdominal Hernia, Inguinal Pharmacologic Actions |